UMIN-ICDS Clinical Trial

Public title

Support for Cancer patients receiving genomics testing and Advanced Therapeutics: A Feasibility Study

Acronym

S-CAT Feasibility Study

Scientific Title

Support for Cancer patients receiving genomics testing and Advanced Therapeutics: A Feasibility Study

Scientific Title:Acronym

S-CAT Feasibility Study

Region

Japan

Condition

Advanced cancer

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Pneumology
Hematology and clinical oncology	Dermatology	Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This feasibility study aims to evaluate the feasibility of implementing, in clinical practice, a support program designed to alleviate distress among patients undergoing comprehensive genomic profiling testing. The program consists of follow-up provided by an interventionist using a checklist after the consultation in which the test results are explained.

Basic objectives2

Others

Basic objectives -Others

Feasibility of implementing the support program in clinical practice

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Intervention completion rate for the support program implemented after the consultation in which the comprehensive genomic profiling (CGP) test results are explained. Intervention completion is defined as completion and collection of the patient checklist and, when support is required, completion of the specified follow-up response. The intervention completion rate is calculated by dividing the number of patients who complete the intervention by the total number of registered patients.

Key secondary outcomes

1.Feasibility indicators
The study consent rate will be assessed at study enrollment. The checklist distribution rate, checklist collection rate, and follow-up response implementation rate will be assessed during and at the completion of the intervention conducted after the consultation in which the comprehensive genomic profiling test results are explained.
2.Acceptability indicators
Patients'perceived burden of completing the checklist and their satisfaction with the overall intervention will be assessed at the completion of the intervention using 5-point Likert scales. The perceived burden on interventionists will also be assessed using a 5-point Likert scale after delivery of the intervention.
3.Exploratory psychological outcomes
Depressive symptoms and the psychosocial impact of CGP testing will be assessed using the Patient Health Questionnaire-9 and the MICRA-CGP, respectively, before and after the intervention. These outcomes will be evaluated exploratorily to examine how the intervention is associated with patients'psychological distress and their perceptions of the CGP testing experience.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

All registered patients will receive a single session support program using a checklist after the consultation in which the results of comprehensive genomic profiling testing are explained.
After the results disclosure consultation, each patient will complete the checklist. The interventionist will review the responses to assess the patient's understanding, questions, concerns, and need for support. When necessary, the interventionist will provide follow up tailored to the identified needs, including supplementary explanations, responses to questions, confirmation of understanding, and referral or guidance to appropriate consultation and support services.
The intervention will be considered complete when the checklist has been completed and collected and, for patients identified as requiring support, the specified follow-up response has been completed.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients receiving outpatient care at the National Cancer Center Hospital.
2. Patients who have been informed of their cancer diagnosis.
3. Patients with a solid tumor who have agreed to undergo comprehensive genomic profiling (CGP) testing.
4. Patients who are able to provide informed consent to participate in the study.
5. Patients aged 18 years or older who are able to read and understand the Japanese-language information sheet and questionnaires and complete the questionnaires independently.

Key exclusion criteria

1. Patients referred from a medical institution other than the National Cancer Center Hospital for the purpose of undergoing CGP testing.
2. Patients undergoing CGP testing for a hematologic malignancy.
3. Patients undergoing CGP testing under the Advanced Medical Care A framework.
4. Patients who are participating or planning to participate during the study period in another interventional study, including a psychological support study, communication intervention study, or clinical trial.
5. Patients who are considered by the attending physician to be unable to participate in the study.

Target sample size

40

Name of lead principal investigator

1st name	Maiko
Middle name
Last name	Fujimori

Organization

National Cancer Center Institute for Cancer Control

Division name

Division of Survivorship

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, JAPAN

TEL

03-3547-5201

Email

mfujimor@ncc.go.jp

Name of contact person

1st name	Maiko
Middle name
Last name	Fujimori

Organization

National Cancer Center Institute for Cancer Control

Division name

Division Survivorship

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, JAPAN

TEL

03-3547-5201

Homepage URL

Email

mfujimor@ncc.go.jp

Institute

National Cancer Center

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Cancer Center Research Ethics Review Committee

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan

Tel

03-3542-2511

Email

irst@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

20

Day

Date of IRB

2026

Year

07

Month

27

Day

Anticipated trial start date

2026

Year

08

Month

12

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

10

Day

Last modified on

2026

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071493